K232833
- 510(k) number
- K232833
- Device name
- HALO AP Dx
- Applicant
- Indica Labs, Inc. NM · US
- Product code
- PSY — Whole Slide Imaging System
- Decision date
- 2024-05-07
- Date received
- 2023-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
510(k) Summary (official FDA PDF): K232833.pdf
Official FDA record: K232833
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.